RecruitingNCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

Sponsor

Abbott Medical Devices

Enrollment

8,744 participants

Start Date

Jun 21, 2022

Study Type

OBSERVATIONAL

Conditions

Arrythmia Bradycardia Cardiac Pacemaker

Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location
Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
OR
Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria1

None

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Interventions

DEVICEAveir VR Leadless Pacemaker System

This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.

DEVICESingle-Chamber Transvenous Pacemaker

This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.